BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 2203588 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04555
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    February 23, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. CRITICAL RAM PARITY ERROR LOGGED ON (B)(6) 2011 IN ADDRESS "1A F0". POR (POWER ON RESET) SEVERITY IS CONSIDERED LOW AS DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. DEVICE WAS NOT RETURNED, BUT DIAGNOSTIC INFORMATION IS CONSISTENT WITH REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET OCCUR DURING THE PREVIOUS TRANSMISSION. IT WAS FURTHER REPORTED THROUGH FOLLOW UP THAT THIS WAS A REMOTE CHECK AND THE CLINIC HAS NOT SEEN THE PATIENT SINCE. THERE WAS NO INTERVENTION DUE TO THE POWER ON RESET AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other 4076 X2 IMPLANTABLE PACING LEADS